Cleared Traditional

GlidePath Retro Long-Term Hemodialysis Catheter

K203575 · C.R. Bard, Inc. · Gastroenterology & Urology
Jul 2021
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K203575 is an FDA 510(k) clearance for the GlidePath Retro Long-Term Hemodialysis Catheter, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 1, 2021, 206 days after receiving the submission on December 7, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K203575 FDA.gov
FDA Decision Cleared SESK
Date Received December 07, 2020
Decision Date July 01, 2021
Days to Decision 206 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MSD — Catheter, Hemodialysis, Implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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